Korro

Biopharmaceutical

PrincipalScientist,AnalyticalSciences

$160–190k Cambridge, Massachusetts, United States FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Senior candidates.

The Brief

“Principal Scientist, Analytical Sciences at Korro. Skills: Analytical Sciences, Oligonucleotide therapeutics, Method development, Method validation. Serve as SME for synthetic oligonucleotide-based drug substance. Develop and optimize analytical methods”

Industry & Context.

Biopharmaceutical
Problems you'll solve

Troubleshooting; Root cause analysis; OOS investigations; OOT investigations

What They're Looking For.

Must Have

PhD in Analytical, Organic Chemistry, or related field with 3+ years’ or MS with 7+ years or BS with 10+ years of relevant industry experience, 3+ years of hands-on experience in analytical method development for small molecule therapeutics, Expertise in chromatographic (e.g., LC-UV, and LC-MS) and spectroscopic techniques (e.g., UV-Vis), Experience with compendial methods used to release sterile products, Familiarity with HRMS analysis in the identification of DS impurities, Functioning knowledge of the chemical principles of molecular degradation pathways, understanding of cGMP and ICH guidelines for analytical aspects of small molecule sterile products in clinical development, Experience with supporting design and management of stability studies, Managed transfer, qualification, and ideally validation of methods, Supported batch disposition, OOS, OOT, and investigations, Excellent written and verbal communication skills, Ability to work collaboratively in a fast-paced environment, Manage multiple projects simultaneously

Nice to Have

Experience in synthetic oligonucleotide therapeutics is desired, understanding of method validation requirements, compendial method verification, primary and working reference standard qualification, aliquoting, and long-term management

What You'll Do.

Serve as SME for synthetic oligonucleotide-based drug substance

Develop and optimize analytical methods

Support analytical method validation

Support analytical method transfer

Support analytical method troubleshooting

Ensure compliance with cGMP standards

Collaborate with Process/Formulation Development teams

Ensure seamless integration of analytical methods into DS

Interpret complex data

Present complex data to cross-functional teams

Present complex data to senior management

Author technical reports

Author sections of regulatory filings

Assist in managing external analytical collaborations with CROs

Ensure data quality from CROs and CMOs

Ensure timelines from CROs and CMOs are met

Stay current with emerging analytical technologies

Apply innovative solutions to improve method robustness

Apply innovative solutions to improve method efficiency

Support investigations for OOS results

Support root cause analyses for OOS results

Support investigations for deviations

Support root cause analyses for deviations

Support investigations for process failures

Support root cause analyses for process failures

How You'll Work.

Team & Collaboration

Cross-functional teams; External partners; Process/Formulation Development teams; CROs; CMOs

Communication Scope

Written communication; Verbal communication; Technical reports; Regulatory documents

Process & Methodology

Manage multiple projects

Full Job Description

## Description Company Summary: Korro is a biopharmaceutical company focused on developing a new class of genetic medicines for both rare and highly prevalent diseases using its proprietary RNA editing platform. Korro is generating a portfolio of differentiated programs that are designed to harness the body’s natural RNA editing process to effect a precise yet transient single base edit. By editing RNA instead of DNA, Korro is expanding the reach of genetic medicines by delivering additional precision and tunability, which has the potential for increased specificity and improved long-term tolerability. Using an oligonucleotide-based approach, Korro expects to bring its medicines to patients by leveraging its proprietary platform with precedented delivery modalities, manufacturing know-how, and established regulatory pathways of approved oligonucleotide drugs. Korro is based in Cambridge, Massachusetts. We are collaborative and united by a common mission. We are building a company with extraordinary people with an audacious vision to create transformative genetic medicines for prevalent diseases. Our values - Rewrite the future, On the Cutting Edge, Better Together, Dynamically Different, Kindness and Integrity form the fabric of the organization. They are reinforced daily and serve as key dimensions in the hiring process to help us ensure that Korro is a magnet for outstanding talent and a great place to work. Join us as we redefine what's possible in genetic medicine and work to make a lasting impact on human health. Korro Bio is seeking an experienced analytical scientist to join the growing CMC team. You will focus on management of CMO analytical labs as well as development of analytical methods, characterization of impurities, degradation pathways, and transfer, qualification/validation of analytical methods for synthetic oligonucleotide-based therapies. This role will support and manage - the quality and stability of drug substances and drug products throughout

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